Essential TremorNCT02763865
A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential Tremor
A study testing MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil in people with Essential Tremor, run by Medical University of South Carolina.
Trial summary
The purpose of this study is to determine the effects of Low Frequency Repetitive Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to 21 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 of age
- Meet the diagnostic criteria for essential tremor with visible upper limb tremor
- Must be either on stable medications to treat tremor for 30 days, or no medications to treat tremor
Who cannot join
- History of seizures
- History of chronic pain conditions
- Any metal in their body above their shoulders
- Use of medications that lower seizure threshold including:
- broad classes of drugs such as tricyclic antidepressants
- anti-psychotics
Show all 9Show fewer
- neuroeptics
- thyroid medications and stimulants
- Use of any medications that cause tremor, Pregnancy
About this study
Official title: A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential
The purpose of this study is to determine the effects of Low Frequency Repetitive Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET).
Hypothesis: Pre-SMA LF r-TMS will result in a >30% reduction in tremor as measured by the TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the pre-SMA effects tremor in patients with ET.
Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing pre-SMA output, and improving motor control, as determined shortening of the delay in the second agonist burst, seen in ET patients. At conclusion of this study expect to have sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of pre-SMA r-TMS in ET.
- Conditions
- Essential Tremor
- Being tested
- MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil, eSHAM system
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagVenture MagProx100 Stimulator with a Cool-B65 A/P coilDevice
Active rTMS administration (1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total.
Resting motor threshold assessment the TMS machine will initially be set to 50% of its maximal output.
eSHAM systemDevice
implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)
| Study group | Role | What they receive |
|---|---|---|
| Active pre-SMA rTMS | Experimental | The intervention to be administered is the MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil l to administer active rTMS at 1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total. Two Thymapad Stimulus Electrodes will be placed in the appropriate position during active rTMS administration.This intervention method will be used for all 15 treatment sessions (20 minutes/session). Receives: Device: MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil |
| Sham pre-SMA rTMS | Sham comparator | The intervention to be administered is the eSHAM system used in conjunction with the MagVenture MagProx100 Stimulator with the Cool-B65 A/P Coil. For eSHAM administration two Thymapad Stimulus Electrodes will be placed on the scalp location that corresponded to left DLPFC. This intervention method will be used for all 15 treatment sessions (20 minutes/session). Previous studies have shown the eSHAM system effectively blinds participants to rTMS treatment (active versus sham). Receives: Device: eSHAM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean TRS (Tremor Rating Score)
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Measured: Baseline (Visit 2) post intervention
Mean TRS (Tremor Rating Score) at 4 Week Followup
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Measured: 4 week followup(visit 18)
Mean TRS (Tremor Rating Score) at 8 Week Followup
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Measured: 8 week followup (visit 19)
Mean TRS (Tremor Rating Score) at 12 Week Followup
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Measured: 12-week followup(visit 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763865
- Sponsor's protocol ID
- Pro00033680
- Status last verified
- Feb 2019
- First submitted
- 12 Apr 2016
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential
- ClinicalTrials.gov ID
- NCT02763865
- Acronym / sponsor ID
- Pro00033680
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of Low Frequency Repetitive Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET).
Hypothesis: Pre-SMA LF r-TMS will result in a >30% reduction in tremor as measured by the TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the pre-SMA effects tremor in patients with ET.
Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing pre-SMA output, and improving motor control, as determined shortening of the delay in the second agonist burst, seen in ET patients. At conclusion of this study expect to have sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of pre-SMA r-TMS in ET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active pre-SMA rTMS | Experimental | Device: MagVenture MagProx100 Stimulator with a Cool-B65 A/P coilThe intervention to be administered is the MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil l to administer active rTMS at 1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total. Two Thymapad Stimulus Electrodes will be placed in the appropriate position during active rTMS administration.This intervention method will be used for all 15 treatment sessions (20 minutes/session). |
| Sham pre-SMA rTMS | Sham comparator | Device: eSHAM systemThe intervention to be administered is the eSHAM system used in conjunction with the MagVenture MagProx100 Stimulator with the Cool-B65 A/P Coil. For eSHAM administration two Thymapad Stimulus Electrodes will be placed on the scalp location that corresponded to left DLPFC. This intervention method will be used for all 15 treatment sessions (20 minutes/session). Previous studies have shown the eSHAM system effectively blinds participants to rTMS treatment (active versus sham). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 18 of age
- Meet the diagnostic criteria for essential tremor with visible upper limb tremor
- Must be either on stable medications to treat tremor for 30 days, or no medications to treat tremor
Key exclusion criteria (9 listed)
- History of seizures
- History of chronic pain conditions
- Any metal in their body above their shoulders
- Use of medications that lower seizure threshold including:
- Use of any medications that cause tremor, Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagVenture MagProx100 Stimulator with a Cool-B65 A/P coilActive rTMS administration (1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total. Resting motor threshold assessment the TMS machine will initially be set to 50% of its maximal output. | Device | Active pre-SMA rTMS |
| eSHAM systemimplemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham) | Device | Sham pre-SMA rTMS |
Primary outcome
Mean TRS (Tremor Rating Score)
Time frame: Baseline (Visit 2) post intervention
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Mean TRS (Tremor Rating Score) at 4 Week Followup
Time frame: 4 week followup(visit 18)
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Mean TRS (Tremor Rating Score) at 8 Week Followup
Time frame: 8 week followup (visit 19)
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Mean TRS (Tremor Rating Score) at 12 Week Followup
Time frame: 12-week followup(visit 20)
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil in people with Essential Tremor, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean TRS (Tremor Rating Score) (time frame: Baseline (Visit 2) post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.